2013 Cold Chain Michael Lee_PPT

生物医药的发展对冷链发展的推动Thedevelopmentofbio-pharmaindustrydrivestheend-to-endcoldchaindevelopmentMichaelLee2Storagearea:•Establishingoftemperatureprofiles•StorageatcontrolledRT-cool,cold,freezestorage•Regulationsfortheentryofgoods•DistributionandshippingofmedicinalproductsColdChainTopics3ColdChainTopicsColdchainmanagement•Transportvehicles–vehiclevalidation•Choiceofpackaging/channelofdistribution•Implementationofstandardizedstresstests•Protectionoffragilefreight4•Qualitymanagement,organizationandpersonnel•Premisesandstorageareas•Transportvehicles,externalpackagingandlabeling•Distributionandshippingpractice,documentation•Repackagingandre-labeling•Complaints,recallsandreturnedproducts•Shippingstudies•UseoflogisticscompaniesColdChainTopics5•ThelongawaitedEuropeanGDPGuidelinewaspublishedonMarch8,2013.•Therearesomesignificantchangescomparedtothedraft.•TheguidelinewillcomeintoforceonSeptember8,2013.EUGDPGuideline6EUGDPGuidelineThenewGDPGuidelineGuidelineonGoodDistributionPracticeofMedicinalProductsforHumanUse(2013/C68/01)hasbeenpublishedonMarch8,2013intheOfficialJournaloftheEuropeanUnion.7EUGDPGuidelineItlaysdownappropriatetoolstoassistwholesaledistributorsinconductingtheiractivitiesandtopreventfalsifiedmedicinesfromenteringthelegalsupplychainandisofutmostimportancefortheinternationalpharmaceuticallogisticbusiness.8EUGDPGuidelinethemaintenanceofaqualitysystemsettingoutresponsibilities,processesandriskmanagementprinciplesinrelationtowholesaleactivities;9EUGDPGuideline•suitabledocumentationwhichpreventserrorsfromspokencommunication;•sufficientcompetentpersonneltocarryoutallthetasksforwhichthewholesaledistributorisresponsible;10EUGDPGuideline•adequatepremises,installationsandequipmentsoastoensureproperstorageanddistributionofmedicinalproducts;11EUGDPGuideline•appropriatemanagementofcomplaints,returns,suspectedfalsifiedmedicinalproductsandrecalls;•outsourcedactivitiescorrectlydefinedtoavoidmisunderstandings;12EUGDPGuideline•rulesfortransportinparticulartoprotectmedicinalproductsagainstbreakage,adulterationandtheft,andtoensurethattemperatureconditionsaremaintainedwithinacceptablelimitsduringtransport;•specificrulesforbrokers(personinvolvedinactivitiesinrelationtothesaleorpurchaseofmedicinalproducts).13EUGDPGuidelineWholesaledistributionofmedicinalproductsisallactivitiesconsistingofprocuring,holding,supplyingorexportingmedicinalproducts,apartfromsupplyingmedicinalproductstothepublic.Suchactivitiesarecarriedoutwithmanufacturersortheirdepositories,importers,otherwholesaledistributorsorwithpharmacistsandpersonsauthorizedorentitledtosupplymedicinalproductstothepublicintheMemberStateconcerned.14EUGDPGuidelineTheGDPGuidelinewillenterintoforceonSeptember8,2013.Pleasenotethattheobligationtorecordthebatchnumberwillonlyenterintoforce3yearsafterthedelegatedactonthesafetyfeaturesisadoptedbytheCommission(adoptionforeseenin2014).15Biopharmaceuticalsmarketin2009Overallbiopharmaceuticalmarket:USD239billionby201516HealthcareMarketStatistics•MarketworthapproximatelyUS$680bn.•Temperature-controlledmarket$168bn.•HealthcaremarketforecasttogrowtoUS$900bnby2012.•Nearly100%ofallvaccinesand65%ofbiotechproductsneedtemperaturecontrolledstorageandtransportation.•Biotechmarketfastestgrowth–majoritybyaircargo.17‘ColdChain’ProductsGrowingFasterColdChainProducts+27%$773bn$187bn$147bn$877bnTotalMarket+13%$BillionsGlobalBiopharmaSales2008-2011Source:PharmaceuticalCommerce18TheSupplyChainSuppliersManufacturersWarehouses&DistributionCentersCustomersMaterialCostsTransportationCostsTransportationCostsTransportationCostsInventoryCostsManufacturingCostsColdChainStepsDistributors&ConsigneesOriginForwarders&TruckingCo’s.Origin-DestinationAirCarrierDestinationForwarders&TruckingCo’sManufacturers&ShippersAirportGroundHandlersThermalSolutionProvidersAirportGroundHandlers20Distributors&ConsigneesOriginForwarders&TruckingCo’s.Origin-DestinationAirCarrierDestinationForwarders&TruckingCo’sManufacturers&ShippersAirportGroundHandlersThermalSolutionProvidersAirportGroundHandlers23%57%20%KeyAreasofColdChainRisk21ExtremeTemperatures-23℃+40℃22ExtremeTemperaturesColdchainsinhealtharecomplex2324ColdChainDistributionofProductsisComplex2526MostFrequentlyReportedUKGoodDistributionPractices(GDP)DeficienciesDescription%Generalstorage–temp.control/monitoring29.8Returns14.9Lackofinadequatewrittenprocedures12.8Unauthorizedactivity10.6Coldstorage–temp.control/monitoring6.4Housekeepingandpestcontrol6.4Coldchaintransportation6.4Customerstatus4.3Premises4.3DutiesoftheResponsiblePerson2.143%ofcriticalandmajordeficienciesrelatedtothecontrolandmonitoringofthestorageandtransportationtemperaturesWhodependsonColdChain?TheyDo!28293031333435363738|39|Contents1.Introduction2.Scopeofthedocument3.Glossary4.Generalprinciples5.Regulationofthedistributionofpharmaceuticalproducts6.Organizationandmanagement7.Personnel8.Qualitysystem9.Premises,warehousingandstorage10.Vehiclesandequipment11.Shipmentcontainersandcontainerlabeling12.Dispatch13.Transportationandproductsintransit14.Documentation15.Repackagingandrelab